Trial Outcomes & Findings for Safety, Reactogenicity and Immunogenicity Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women (NCT NCT02360475)

Results Overview

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 100 millimeters (mm).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

507 participants

Primary outcome timeframe

During the 7-day (Days 0-6) post-vaccination period

Results posted on

2018-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	GSK3003891A 30 Non-adjuvanted Group Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Non-adjuvanted Group Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Adjuvanted Group Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	Boostrix Group Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
Overall Study STARTED	126	124	125	125
Overall Study COMPLETED	122	111	117	120
Overall Study NOT COMPLETED	4	13	8	5

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK3003891A 30 Non-adjuvanted Group Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Non-adjuvanted Group Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Adjuvanted Group Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	Boostrix Group Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
Overall Study Lost to Follow-up	4	12	6	4
Overall Study Withdrawal by Subject	0	1	2	0
Overall Study Migrated/moved from study area	0	0	0	1

Baseline Characteristics

Safety, Reactogenicity and Immunogenicity Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK3003891A 30 Non-adjuvanted Group n=126 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Non-adjuvanted Group n=124 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Adjuvanted Group n=125 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	Boostrix Group n=125 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	Total n=500 Participants Total of all reporting groups
Age, Continuous	29.2 Years STANDARD_DEVIATION 7.5 • n=5 Participants	29.5 Years STANDARD_DEVIATION 8.2 • n=7 Participants	29.1 Years STANDARD_DEVIATION 7.4 • n=5 Participants	29.2 Years STANDARD_DEVIATION 7.9 • n=4 Participants	29.25 Years STANDARD_DEVIATION 7.73 • n=21 Participants
Sex: Female, Male Female	126 Participants n=5 Participants	124 Participants n=7 Participants	125 Participants n=5 Participants	125 Participants n=4 Participants	500 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized African Heritage / African American	5 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	9 Participants n=4 Participants	30 Participants n=21 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	12 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized White-Arabic / North African Heritage	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants
Race/Ethnicity, Customized White-Caucasian/European Heritage	112 Participants n=5 Participants	114 Participants n=7 Participants	97 Participants n=5 Participants	108 Participants n=4 Participants	431 Participants n=21 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	11 Participants n=21 Participants

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented and with the symptoms sheet filled in.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 100 millimeters (mm).

Outcome measures

Outcome measures
Measure	GSK3003891A 30 Non-adjuvanted Group n=124 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Non-adjuvanted Group n=119 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Adjuvanted Group n=124 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	Boostrix Group n=124 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
Number of Subjects With Solicited Local Symptoms Grade 3 Swelling	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms Any Pain	62 Participants	68 Participants	104 Participants	104 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Pain	1 Participants	2 Participants	9 Participants	3 Participants
Number of Subjects With Solicited Local Symptoms Any Redness	6 Participants	3 Participants	8 Participants	6 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Redness	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms Any Swelling	7 Participants	6 Participants	12 Participants	5 Participants

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented and with the symptoms sheet filled in.

Assessed solicited general symptoms (symp.) were headache, fever \[defined as oral temperature (temp.) equal to or above 37.5 degrees Celsius (°C)\], fatigue, gastrointestinal (Gastro.) symptoms \[nausea, vomiting, diarrhoea and/or abdominal pain\]. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 (G3) symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	GSK3003891A 30 Non-adjuvanted Group n=124 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Non-adjuvanted Group n=119 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Adjuvanted Group n=124 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	Boostrix Group n=124 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
Number of Subjects With Solicited General Symptoms G3 Headache	3 Participants	2 Participants	5 Participants	3 Participants
Number of Subjects With Solicited General Symptoms Related Headache	37 Participants	33 Participants	39 Participants	33 Participants
Number of Subjects With Solicited General Symptoms G3 Temp.	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms Any Fatigue	53 Participants	50 Participants	56 Participants	45 Participants
Number of Subjects With Solicited General Symptoms G3 Fatigue	8 Participants	1 Participants	4 Participants	2 Participants
Number of Subjects With Solicited General Symptoms Related Fatigue	44 Participants	41 Participants	50 Participants	39 Participants
Number of Subjects With Solicited General Symptoms Any Gastro. symp.	16 Participants	19 Participants	23 Participants	20 Participants
Number of Subjects With Solicited General Symptoms G3 Gastro. symp.	1 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Solicited General Symptoms Related Gastro. symp.	9 Participants	14 Participants	21 Participants	17 Participants
Number of Subjects With Solicited General Symptoms Any Headache	47 Participants	44 Participants	53 Participants	39 Participants
Number of Subjects With Solicited General Symptoms Any Temp.	7 Participants	9 Participants	12 Participants	7 Participants
Number of Subjects With Solicited General Symptoms Related Temp.	5 Participants	8 Participants	11 Participants	6 Participants

PRIMARY outcome

Timeframe: During the 30-Day (Days 0-29) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	GSK3003891A 30 Non-adjuvanted Group n=126 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Non-adjuvanted Group n=124 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Adjuvanted Group n=125 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	Boostrix Group n=125 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
Number of Subjects With Unsolicited Adverse Events (AEs)	35 Participants	38 Participants	34 Participants	37 Participants

PRIMARY outcome

Timeframe: From vaccination at Day 0, up to Day 30 post-vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	GSK3003891A 30 Non-adjuvanted Group n=126 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Non-adjuvanted Group n=124 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Adjuvanted Group n=125 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	Boostrix Group n=125 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
Number of Subjects With Serious Adverse Events (SAEs)	1 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At Day 0 pre-vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.

RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60).

Outcome measures

Outcome measures
Measure	GSK3003891A 30 Non-adjuvanted Group n=117 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Non-adjuvanted Group n=117 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Adjuvanted Group n=118 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	Boostrix Group n=118 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
Titres of RSV-A Neutralizing Antibodies	397.1 Titres Interval 330.7 to 476.7	326.3 Titres Interval 277.1 to 384.4	444.2 Titres Interval 370.4 to 532.6	423.7 Titres Interval 360.2 to 498.4

PRIMARY outcome

Timeframe: At Day 30 post-vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.

RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60).

Outcome measures

Outcome measures
Measure	GSK3003891A 30 Non-adjuvanted Group n=117 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Non-adjuvanted Group n=117 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Adjuvanted Group n=118 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	Boostrix Group n=118 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
Titres of RSV-A Neutralizing Antibodies	1237.0 Titres Interval 1094.8 to 1397.6	1278.7 Titres Interval 1141.6 to 1432.2	1442.5 Titres Interval 1287.4 to 1616.2	387.1 Titres Interval 328.4 to 456.3

SECONDARY outcome

Timeframe: At Day 60 post-vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.

RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs), were defined as any titre greater than or equal to (≥) the cut-off 8 serum dilution inducing 60 % inhibition in plaque forming units (ED60).

Outcome measures

Outcome measures
Measure	GSK3003891A 30 Non-adjuvanted Group n=109 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Non-adjuvanted Group n=111 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Adjuvanted Group n=108 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	Boostrix Group n=111 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
Titres of RSV-A Neutralizing Antibodies	947.2 Titres Interval 832.9 to 1077.1	882.9 Titres Interval 781.9 to 996.9	1055.7 Titres Interval 926.1 to 1203.4	358.8 Titres Interval 297.8 to 432.3

SECONDARY outcome

Timeframe: At Day 90 post-vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.

RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs), were defined as any titre greater than or equal to (≥) the cut-off 8 serum dilution inducing 60 % inhibition in plaque forming units (ED60).

Outcome measures

Outcome measures
Measure	GSK3003891A 30 Non-adjuvanted Group n=112 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Non-adjuvanted Group n=111 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Adjuvanted Group n=110 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	Boostrix Group n=111 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
Titres of RSV-A Neutralizing Antibodies	837.7 Titres Interval 738.9 to 949.7	774.5 Titres Interval 682.6 to 878.7	897.5 Titres Interval 782.8 to 1029.2	358.3 Titres Interval 291.9 to 439.9

SECONDARY outcome

Timeframe: At Day 0 pre-vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.

Palivizumab competing antibody concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).

Outcome measures

Outcome measures
Measure	GSK3003891A 30 Non-adjuvanted Group n=110 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Non-adjuvanted Group n=107 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Adjuvanted Group n=105 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	Boostrix Group n=110 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
Concentrations of Palivizumab Competing Antibodies (PCA)	5.4 µg/mL Interval 4.7 to 6.3	5.2 µg/mL Interval 4.4 to 6.0	4.6 µg/mL Interval 4.0 to 5.4	5.7 µg/mL Interval 4.8 to 6.7

SECONDARY outcome

Timeframe: At Day 30 post-vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.

PCA concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).

Outcome measures

Outcome measures
Measure	GSK3003891A 30 Non-adjuvanted Group n=115 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Non-adjuvanted Group n=116 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Adjuvanted Group n=116 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	Boostrix Group n=109 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
Concentrations of PCA	79.9 µg/mL Interval 72.1 to 88.6	88.6 µg/mL Interval 79.9 to 98.2	97.2 µg/mL Interval 89.1 to 105.9	6.1 µg/mL Interval 5.3 to 7.1

SECONDARY outcome

Timeframe: At Day 60 post-vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.

PCA concentrations, expressed as Geometric Mean Concentrations (GMCs).The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).

Outcome measures

Outcome measures
Measure	GSK3003891A 30 Non-adjuvanted Group n=109 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Non-adjuvanted Group n=111 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Adjuvanted Group n=108 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	Boostrix Group n=111 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
Concentrations of PCA	65.9 µg/mL Interval 57.8 to 75.1	68.4 µg/mL Interval 61.5 to 75.9	74.1 µg/mL Interval 66.6 to 82.3	5.8 µg/mL Interval 5.0 to 6.7

SECONDARY outcome

Timeframe: At Day 90 post-vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.

PCA concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).

Outcome measures

Outcome measures
Measure	GSK3003891A 30 Non-adjuvanted Group n=112 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Non-adjuvanted Group n=111 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Adjuvanted Group n=110 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	Boostrix Group n=109 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
Concentrations of PCA	60.4 µg/mL Interval 54.0 to 67.6	62.5 µg/mL Interval 56.7 to 68.9	66.1 µg/mL Interval 59.9 to 73.0	7.5 µg/mL Interval 6.6 to 8.6

SECONDARY outcome

Timeframe: Up to study end at Day 360

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented.

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	GSK3003891A 30 Non-adjuvanted Group n=126 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Non-adjuvanted Group n=124 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Adjuvanted Group n=125 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	Boostrix Group n=125 Participants Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
Number of Subjects With SAEs	3 Participants	3 Participants	6 Participants	2 Participants

Adverse Events

GSK3003891A 30 Non-adjuvanted Group

Serious events: 3 serious events

Other events: 93 other events

Deaths: 0 deaths

GSK3003891A 60 Non-adjuvanted Group

Serious events: 3 serious events

Other events: 88 other events

Deaths: 0 deaths

GSK3003891A 60 Adjuvanted Group

Serious events: 6 serious events

Other events: 112 other events

Deaths: 0 deaths

Boostrix Group

Serious events: 2 serious events

Other events: 109 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	GSK3003891A 30 Non-adjuvanted Group n=126 participants at risk Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Non-adjuvanted Group n=124 participants at risk Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Adjuvanted Group n=125 participants at risk Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	Boostrix Group n=125 participants at risk Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
Gastrointestinal disorders Gastrointestinal disorder	12.7% 16/126 • Number of events 16 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	15.3% 19/124 • Number of events 19 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	18.4% 23/125 • Number of events 23 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	16.0% 20/125 • Number of events 20 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.
General disorders Fatigue	42.1% 53/126 • Number of events 53 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	40.3% 50/124 • Number of events 50 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	44.8% 56/125 • Number of events 57 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	36.0% 45/125 • Number of events 46 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.
General disorders Pain	49.2% 62/126 • Number of events 62 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	54.8% 68/124 • Number of events 69 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	83.2% 104/125 • Number of events 105 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	83.2% 104/125 • Number of events 104 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.
General disorders Pyrexia	5.6% 7/126 • Number of events 7 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	8.1% 10/124 • Number of events 10 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	9.6% 12/125 • Number of events 12 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	6.4% 8/125 • Number of events 8 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.
General disorders Swelling	5.6% 7/126 • Number of events 7 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	4.8% 6/124 • Number of events 6 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	9.6% 12/125 • Number of events 12 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	4.0% 5/125 • Number of events 5 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.
Infections and infestations Upper respiratory tract infection	1.6% 2/126 • Number of events 2 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	5.6% 7/124 • Number of events 7 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	2.4% 3/125 • Number of events 3 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	4.8% 6/125 • Number of events 6 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.
Nervous system disorders Headache	38.9% 49/126 • Number of events 53 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	36.3% 45/124 • Number of events 47 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	44.8% 56/125 • Number of events 59 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	32.8% 41/125 • Number of events 43 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.
Skin and subcutaneous tissue disorders Erythema	4.8% 6/126 • Number of events 6 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	2.4% 3/124 • Number of events 3 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	6.4% 8/125 • Number of events 8 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	4.8% 6/125 • Number of events 6 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	GSK3003891A 30 Non-adjuvanted Group n=126 participants at risk Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Non-adjuvanted Group n=124 participants at risk Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	GSK3003891A 60 Adjuvanted Group n=125 participants at risk Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.	Boostrix Group n=125 participants at risk Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
Gastrointestinal disorders Colitis	0.00% 0/126 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/124 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.80% 1/125 • Number of events 1 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/125 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.
Infections and infestations Pneumonia bacterial	0.00% 0/126 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/124 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/125 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.80% 1/125 • Number of events 1 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/126 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/124 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/125 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.80% 1/125 • Number of events 1 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.
Injury, poisoning and procedural complications Musculoskeletal injury	0.00% 0/126 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.81% 1/124 • Number of events 1 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/125 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/125 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.
Nervous system disorders Transient ischaemic attack	0.00% 0/126 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.81% 1/124 • Number of events 1 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/125 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/125 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.
Psychiatric disorders Suicide attempt	0.79% 1/126 • Number of events 1 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/124 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/125 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/125 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/126 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/124 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.80% 1/125 • Number of events 1 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/125 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.
Gastrointestinal disorders Umbilical hernia	0.00% 0/126 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/124 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.80% 1/125 • Number of events 1 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/125 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.
Infections and infestations Erysipelas	0.00% 0/126 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/124 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.80% 1/125 • Number of events 1 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/125 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/126 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/124 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.80% 1/125 • Number of events 1 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/125 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/126 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/124 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.80% 1/125 • Number of events 1 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/125 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/126 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/124 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.80% 1/125 • Number of events 1 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/125 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.
Musculoskeletal and connective tissue disorders Jaw cyst	0.79% 1/126 • Number of events 1 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/124 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/125 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/125 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/126 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.81% 1/124 • Number of events 1 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.80% 1/125 • Number of events 1 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/125 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.
Respiratory, thoracic and mediastinal disorders Obliterative bronchiolitis	0.79% 1/126 • Number of events 1 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/124 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/125 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.	0.00% 0/125 • Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.